Procedure for assessing the acceptability, in principle, of vaccines ...

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Contents CONTENTS ............................................................................................................................................ 2 ACRONYMS .......................................................................................................................................... 3 1 INTRODUCTION ......................................................................................................................... 4 2 CONDITIONS FOR ACCEPTANCE OF APPLICATIONS ................................................... 6 3 STEPS OF THE PROCEDURE .................................................................................................. 7 3.1 OFFICIAL REQUEST AND RESPONSE ................................................................................................. 8 3.2 MEETINGS WITH MANUFACTURERS ................................................................................................. 8 3.3 PRODUCT SUMMARY FILE (PSF) ..................................................................................................... 9 3.4 INITIAL TESTING OF VACCINE SAMPLES ......................................................................................... 12 3.5 WHO SITE AUDITS ........................................................................................................................ 14 3.6 REPORT AND OUTCOME OF THE ASSESSMENT ................................................................................ 16 4 CONSIDERATIONS FOR STREAMLINING THE PREQUALIFICATION PROCEDURE ON THE BASIS OF ENHANCED ASSISTANCE BY NRAS .......................................................... 18 4.1 PROCEDURE FOR SELECTING ELIGIBLE NRAS ............................................................................... 18 4.2 STREAMLINED PROCEDURE FOR VACCINES WITH MARKETING AUTHORIZATION/LICENSING GRANTED BY ELIGIBLE NRAS ............................................................................................................. 19 4.3 VACCINES WITH POSITIVE SCIENTIFIC OPINION ISSUED BY THE EUROPEAN MEDICINES AGENCY . 23 5 SPECIAL CONSIDERATIONS FOR FAST-TRACK PROCEDURE .................................. 24 6 SPECIAL CONSIDERATIONS FOR ACCEPTING SUBMISSIONS OF VACCINES MANUFACTURED AT MULTIPLE SITES OR IN DIFFERENT COUNTRIES ........................ 25 7 OBLIGATIONS AFTER PREQUALIFICATION IS GRANTED ........................................ 28 8 ANNUAL REPORTING ............................................................................................................ 30 9 REASSESSMENTS .................................................................................................................... 31 10 MONITORING CONTINUED COMPLIANCE WITH SPECIFICATIONS THROUGH TARGETED TESTING ....................................................................................................................... 33 11 MONITORING VACCINE QUALITY COMPLAINTS OR AEFIS FROM THE FIELD . 33 12 RECOMMENDATIONS FOR ACTION IN CASES OF NON-COMPLIANCE ................. 34 13 HANDLING OUT-OF-SPECIFICATION/INCONSISTENT RESULTS BETWEEN LABORATORIES ................................................................................................................................ 35 14 COSTS ......................................................................................................................................... 35 15 CONFIDENTIALITY ................................................................................................................ 36 16 CONFLICT OF INTEREST ...................................................................................................... 37 AUTHORS ............................................................................................................................................ 39 ACKNOWLEDGMENTS .................................................................................................................... 43 REFERENCES ..................................................................................................................................... 44 APPENDIX 1 THE PRODUCT SUMMARY FILE .......................................................................... 46 APPENDIX 2 FLOWCHARTS OF WHO PREQUALIFICATION FOR VACCINES ................ 58 APPENDIX 3 TESTING APPROACH FOR INITIAL EVALUATION FOR PREQUALIFICATION ....................................................................................................................... 63 APPENDIX 4 PREQUALIFICATION PROCEDURE FOR VACCINES EVALUATED BY EMA UNDER ARTICLE 58 OF REGULATION (EC) NO 726/2004 ............................................. 67 APPENDIX 5 CONFIDENTIALITY AGREEMENT ...................................................................... 71 APPENDIX 6 DECLARATION OF INTERESTS FOR WHO EXPERTS .................................... 73 2
Acronyms The following acronyms are used in this document. AEFI adverse event following immunization AHU air-handling unit AMC Advance Market Commitment CHMP Committee for Medicinal Products for Human Use CTD Common Technical Document EMA European Medicines Agency GAVI Global Alliance for Vaccines and Immunization GCP good clinical practice GMP good manufacturing practice HIV human immunodeficiency virus ICH International Conference on Harmonization IPAC Immunization Practices Advisory Committee IVB Department of Immunization, Vaccines and Biologicals (WHO) NRA national regulatory authority NCL national control laboratory OMCL Official Medicine Control Laboratories PSF product summary file PSPQ programmatic suitability of vaccines for prequalification PSUR periodic safety updated report QSS Quality, Safety and Standards (WHO) SAGE Strategic Advisory Group of Experts TPP target product profile UN United Nations UNICEF United Nations Children’s Fund VVM vaccine vial monitor WHO World Health Organization 3
Page 1: Procedure for assessing the accepta
Page 5 and 6: The prequalification procedure esta
Page 7 and 8: • The candidate vaccine meets the
Page 9 and 10: Such meetings are important for dis
Page 11 and 12: immunization programmes and vaccine
Page 13 and 14: As soon as the PSF is accepted and
Page 15 and 16: manufacturer, to organize an abbrev
Page 17 and 18: with both the WHO requirements and
Page 19 and 20: o review and approval of variations
Page 21 and 22: − confirmation that the vaccine m
Page 23 and 24: collaborative effort. Special atten
Page 25 and 26: for submission of PSFs do not apply
Page 27 and 28: In cases where the vaccine manufact
Page 29 and 30: WHO reserves the right to take appr
Page 31 and 32: C. The manufacturer should provide
Page 33 and 34: If, as a result of the reassessment
Page 35 and 36: In the event of situations as descr
Page 37 and 38: identifying the confidential inform
Page 39 and 40: Authors The proposals for the revis
Page 41 and 42: Geneva, Switzerland; Dr U Rosskopf,
Page 43 and 44: Acknowledgments Acknowledgements ar
Page 46 and 47: Appendix 1 The product summary file
Page 48 and 49: 3.3 Describe ventilation systems in
Page 50 and 51: For recombinant vaccines, a descrip
Page 52 and 53:
7.3 Provide information on stabilit
Page 54 and 55:
particular attention to any data th
Page 56 and 57:
9.3 Summarize the arrangements and
Page 58 and 59:
Appendix 2 Flowcharts of WHO prequa
Page 60 and 61:
Request/supply of Additional Data Y
Page 62 and 63:
Satisfactory Completion of PSF revi
Page 64 and 65:
4 5 oversight. Validation of the cr
Page 66 and 67:
9 10 the critical tests • Review
Page 68 and 69:
68 WHO/BS/10.2155 Page 68 1) An app
Page 70 and 71:
70 WHO/BS/10.2155 Page 70 http://ww
Page 72 and 73:
72 WHO/BS/10.2155 Page 72 1) may ha
Page 74 and 75:
74 WHO/BS/10.2155 Page 74 meeting o
Page 76 and 77:
the meeting or work? 4a Patents, tr
Page 78:
true and complete to the best of my
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